DECISION OF THE EEA JOINT COMMITTEE No 305/2022

of 9 December 2022

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2023/1247]

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (“the EEA Agreement”), and in particular Article 98 thereof,

Whereas:

(1) Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products  ( 1 ) is to be incorporated into the EEA Agreement.

(2) Annex II to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

The following point is inserted after point 22i (Regulation (EU) 2022/839 of the European Parliament and of the Council) of Chapter XIII of Annex II to the EEA Agreement:

‘22j.

32021 R 1281 : Commission Implementing Regulation (EU) 2021/1281 of 2 August 2021 laying down rules for the application of Regulation (EU) 2019/6 of the European Parliament and of the Council as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products ( OJ L 279, 3.8.2021, p. 15 ).’

Article 2

The text of Implementing Regulation (EU) 2021/1281 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union , shall be authentic.

Article 3

This Decision shall enter into force on 10 December 2022, provided that all the notifications under Article 103(1) of the EEA Agreement have been made  ( *1 ) .

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union .

Done at Brussels, 9 December 2022.

For the EEA Joint Committee

The President

Kristján Andri STEFÁNSSON

( 1 )    OJ L 279, 3.8.2021, p. 15 .

( *1 )   No constitutional requirements indicated.